Transvaginal Mesh Lawsuits

It became common in the 1990s to use surgical mesh in transvaginal repair procedures for pelvic organ prolapse and stress urinary incontinence. By inserting a mesh device transvaginally, the procedure offered a minimally invasive alternative to traditional surgeries. However, recent research from the FDA has found these transvaginal mesh procedures may be harmful to patients — putting them at risk of mesh erosion, pain, additional surgeries, and in rare cases, even death.

What You Can Do & How We Can Help

The Schmidt Firm, LLP is currently accepting transvaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by transvaginal mesh, you should contact our firm immediately for a free case consultation. Please use the form below to contact our transvaginal mesh Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Vaginal Mesh: An Overview

Pelvic organ prolapse (POP) is a condition that occurs when the muscles and tissue around the pelvic organs weaken or stretch, causing the organs to bulge into the vaginal wall. Conversely, stress urinary incontinence occurs when there is a leakage of urine during moments of physical activity, which may include coughing, sneezing, laughing or exercise

Vaginal mesh is one option used to treat POP and SUI. In 1996, the FDA cleared the first surgical mesh product for use in SUI procedures. And in 2002, it cleared the first for POP procedures.

When used in transvaginal POP repair, mesh is inserted through small stitches made in the vaginal wall (also known as “transvaginal”) to reinforce the weakened vaginal wall and support bulging organs. For SUI repair, the mesh is used as a sling to support the urethra.

In 2010, the FDA reports approximately 300,000 women underwent surgical procedures in the United States to repair POP — 260,000 underwent SUI repair procedures. One out three POP surgeries used mesh, and 75% of the mesh POP procedures were done transvaginally. For SUI surgeries, 80% were done with transvaginal mesh.

Unfortunately, in 2008 and again in July of 2011, the FDA warned of the possible adverse side effects of surgically implanted transvaginal mesh. To date, the FDA has received over 3,874 reports of injury, death and malfunction occurring after transvaginal mesh procedures.

The most common complications included erosion of mesh through the vagina (also known as exposure, extrusion or protrusion), pain, dyspareunia, infection, urinary problems, bleeding, and organ perforation. There were additional reports of recurring prolapse or incontinence, neuro-muscular problems, vaginal scarring or shrinkage, and emotional problems. Some of these symptoms required hospitalization and additional surgery, sometimes even to remove the mesh.

Due to the severity of symptoms associated with transvaginal mesh, transvaginal mesh patients may want to contact a transvaginal mesh lawyer or transvaginal mesh attorney with The Schmidt Firm, LLP to discuss the potential for a transvaginal mesh lawsuit.

Side Effects of Transvaginal Mesh

The following side effects are associated with transvaginal mesh complications:

Erosion through the vagina
Infection
Bleeding
Organ perforation (bowel, bladder and blood vessel)
Additional repair surgery
Severe pelvic of vaginal pain
Painful sexual intercourse (dyspareunia)
Inability to engage in sexual intercourse
Recurring prolapse or incontinence
Neuro-muscular problems
Vaginal scarring
Mesh contraction
Vaginal shortening/shrinking

What is Transvaginal Mesh?

Mesh materials can be divided into four general categories:

Non-absorbable synthetic (polypropylene or polyester)
Absorbable synthetic
Biological (acellular collagen derived from bovine or porcine sources)
Composite (combination of any of the previous three categories)

Most meshes used in transvaginal surgeries are composed of non-absorbable synthetic polypropylene.

Usually, the mesh is configured or cut to match the organ defect it is correcting.

Pelvic Organ Prolapse (POP)

Pelvic organ prolapse occurs when the tissue surrounding pelvic organs becomes weakened or stretched, often from childbirth. While it is commonly associated with pregnancy, it can occur even if a woman has never had children. It causes organs (including the bladder, uterus, bowel, rectum and top of the vagina) to bulge into the vagina. More than one organ may prolapse at once and they may prolapse past the vaginal opening.

POP is also called a dropped bladder, dropped uterus, dropped vagina, dropped rectum, cystocele, rectocele, or enterocele.

Anywhere between 30-50 percent of women will experience POP during their lifetime, but only 2 percent will develop symptoms. Most cases can be treated through exercise or vaginal inserts called pessaries. However, women have an 11 percent lifetime incidence of having POP or SUI surgically repaired. Surgical repair may be done abdominally or transvaginally.

Symptoms of POP include vaginal lump, constipation, difficulty emptying the bowel or bladder and/or problems with sexual intercourse.

The following factors may contribute to the onset of POP: smoking, menopause, obesity, family history, pelvic trauma, previous surgeries, multiple vaginal deliveries, diabetes, and connective tissue disorders.

Stress Urinary Incontinence (SUI)

Stress urinary incontinence affects anywhere between 20-40 percent of women. It is characterized by a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing or exercise.

It can be treated through exercise or surgery, either done abdominally or transvaginally. When treated transvaginally, a synthetic sling is placed under the urethra to prevent urinary loss during physical activity.

Synthetic Mesh Manufacturers

In 2008, the FDA stated nine manufacturers were mentioned in the reports of post-surgical transvaginal mesh complications. The majority of adverse events have been noted among products made by:

Johnson & Johnson
Boston Scientific Corp.
American Medical Systems
Cook
Covidien
CR Bard

Other complaints have also been made about products made by:

General Medical Devices
Caldera Medical
Ethicon, Inc.
Endo Pharmaceuticals

FDA Warning

October 20, 2008 — On this date, the FDA released a Public Health Notification, warning patients and doctors of over 1,000 reports of complications associated with transvaginal placement of surgical mesh in repair of POP and SUI.

At the time, the FDA stated that the complications were reported in rare cases. The most commonly reported side effect was erosion through the vaginal wall, but other complications included pain, urinary problems, recurrence, organ perforation and vaginal scarring. The FDA reported that cases of vaginal scarring and erosion caused a decrease in patient quality of life and pain, including dyspareunia.

The notification recommended surgeons receive specialized training on mesh placement techniques, be vigilant about adverse events, watch for complications associated with tool use, and warn patients about complications and remind them that the implant is permanent.

Previously, the FDI had approved transvaginally placed surgical mesh as a Class II product, regulated under the 510(k) model.

July 13, 2011 — The FDA updated its 2008 Public Health Notification with a Safety Communication.

Most notably, the FDA reported that complications were not rare, contrary the the FDA’s previous statement. Additionally, the complications may be life-altering.

On top of the 1,000 reports of complications received prior to its 2008 notification, the FDA received an additional 2,874 reports of injury, death and malfunction. 1,503 were associated with POP repairs, while 1,371 were associated with SUI repairs. There were also seven deaths linked to POP repairs. Three of the deaths were directly associated with mesh placement procedures. It appeared post-operative medical complications led to the other four.

Additionally, the FDA reported patients who received a transvaginal mesh procedure were at greater risk of complications over patients who received traditional non-mesh procedures. Synthetic mesh vaginal procedures introduced risks not present in other non-mesh surgeries. The FDA also suggested transvaginal POP repair does not appear to provide any benefit compared to traditional surgeries without mesh — it does not improve quality of life.

The updated report also included a risk that was unknown as of 2008. In the adverse events reported between 2008 and 2011, a new risk of mesh contraction (shrinkage) was reported. Mesh contraction was associated with vaginal shortening, vaginal tightening and vaginal pain.

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